Restylane Silk Microinjections to Cheeks

NCT03742479 | Unknown FDA Device

• 1 other identifier: Silkcheek-2018-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the efficacy and safety of Restylane® Silk microinjections when used in a grid-like injection pattern for the correction of fine lines to the cheeks.

Conditions

Wrinkle

Outcome Measures

Primary Outcomes (3)

• Investigator five point global aesthetic improvement score

  Change in Investigator five point global aesthetic improvement score from Baseline at all follow up visits through month 6 using Investogator's Global Aesthetic Improvement Scale

  Baseline to 6 - Months Post Final Treatment

• Cutometer Measured Skin Elaticity

  Change in elasticity from baseline to the last visit measured using a Cutometer

  Baseline to 6 - Months Post Final Treatment

• Hydrometer measured Transepidermal Water Loss

  Change in transepidermal waterloss from baseline to the last visit measured using a hydrometer.

  Baseline to 6 - Months Post Final Treatment

Secondary Outcomes (1)

• Safety - Injection Site Adverse Events

  Baseline to 6 - Months Post Final Treatment

Study Arms (1)

Hyaluronic Acid Microinjection

EXPERIMENTAL

Device: Restylane® Silk

Interventions

Restylane® Silk DEVICE

Injectable Hyaluronic Acid (HA)

Hyaluronic Acid Microinjection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• b. Symmetrical visible sign of aging involving at least a 9 cm2 area of the mid to low cheeks.
• c. Must be willing to give and sign a HIPPA form, photo consent and informed consent form.
• d. Must be willing to comply with study dosing and complete the entire course of the study.
• e. Female patients will be either of non-childbearing potential defined as:
• \. Having no uterus 2. No menses for at least 12 months. Or; (WOCBP) women of childbearing potential must agree to use an effective method of birth control during the course of the study, such as:
• Oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine device
• Intrauterine coil
• Bilateral tubal ligation
• Barrier method used with an additional form of contraception (e.g., sponge, spermicide or condom)
• Abstinence (If practicing abstinence must agree to use barrier method described above (4) if becomes sexually active).
• Vasectomized partner (must agree to use barrier method described above (4) if becomes sexually active with un-vasectomized).
• f. Negative urine pregnancy test results Baseline prior to study entry (if applicable)

You may not qualify if:

• Pregnant, planning pregnancy during the course of the study or breastfeeding
• Extremely Severe aging face with extensive photodamage
• Previous use of any form of soft tissue augmentation in the treatment area within the past 12 months
• Pre-existing medical or dermatologic condition in the treatment area that may affect the treatment or interpretation of treatment effect (at investigator discretion)
• Presence of tattoo and/or scar in the treatment area that in the investigators opinion would interfere with study assessments
• Use of oral/topical retinoids within 1 month of Baseline
• Previous use of botulinum toxins in the treatment area within the past 6 months
• Previous surgical procedure in the treatment area within the past 12 months
• Presence or evidence of any conditions that in the opinion of the investigator might impede the subject's ability to give consent or comply with protocol requirements.
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study
• History of non-compliance with clinical research protocols
• Ablative laser resurfacing to on their face within 12 months
• Non-ablative laser or light procedures to their face within the past 3 months
• Known allergy to Restylane® Silk or any of its constituents

Sponsors & Collaborators

• Goldman, Butterwick, Fitzpatrick and Groff: lead

Study Sites (1)

West Dermatology Research Center

San Diego, California, 92121, United States

RECRUITING

Central Study Contacts

Shannon Quigley

CONTACT

858 657 1004; SQuigley@CLDerm.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Certified Clinical Research Coordinator

Model Details: Single Group, Open Label Study

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 15, 2018
• Study Start: February 26, 2019
• Primary Completion: December 1, 2019
• Study Completion: February 1, 2020
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)